Professional Documents
Culture Documents
and regulation
Workshop report
April 2009
April 2009
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Global health diagnostics
Acknowledgements
This report was prepared by Dr Georgie MacArthur and is published by the Academy of Medical
Sciences. The Academy warmly thanks the Chairman, speakers and delegates for their
participation in the symposium and for their input into this report.
All web references were accessed in March 2009
Academy of Medical Sciences
contents
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Contents
1. Background
2. Introduction
4. Access to diagnostics
13
15
17
19
Conclusions
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25
26
1. Background
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1. Background
This report provides a summary of a workshop
health diagnostics.
list is annexed.
be required.
including:
countries (LMIC).
diagnostic tests.
2. introduction
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2. Introduction
To date, efforts to address the burden of global
vaccines.1
diagnostics facilitates:
resource capacity
investigations.
elimination.
resistance.
efficacy trials.
1M
alaria R&D Alliance (2005). Malaria research and development, an assessment of global investment. http://www.malariaalliance.org/pdfs/
rd_report_complete.pdf
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G lobal health diagnostics
2 Reviewed in Mabey D et al. (2004). Diagnostics for the developing world. Nature Reviews Microbiology 2, 231-240.
delays in availability.
containment facilities.
show that:
biosafety cabinet.
deionised water.
to reduce temperature.3
In addition, failure to store tests at the
affect quality.
3 Data presented by Dr Helen Lee at the Academy of Medical Sciences' workshop, Global health diagnostics: research, development and regulation.
in all settings.
10
4W
isniewski CA et al. (2008). Optimal method of collection of first-void urine for diagnosis of Chlamydia trachomatis infection in men. Journal of
Clinical Microiology 46(4), 1466-9, Mahilum-Tapay L et al. (2007). New point of care Chlamydia rapid test - bridging the gap between diagnosis
and treatment: performance evaluation study. British Medical Journal 335 (7631), 1190-4.
proportion of
patients.5
5G
ift TL (1999). The rapid test paradox: when fewer cases detected lead to more cases treated: a decision analysis of tests for Chlamydia
trachomatis. Sexually Transmitted Diseases 26(4), 232-40.
11
12
4. Access to Diagnostics
4. Access to diagnostics
The marked imbalance of resources available
indicate that:
actually treated.7
congenital syphilis.
6W
orld Health Organization (2001). Global prevalence and incidence of selected curable sexually transmitted infections: overview and estimates.
WHO. Geneva, World Health Organization (2005). Projections of mortality and burden of disease to 2030. WHO, Geneva.
7 Data presented by Professor Rosanna Peeling at the Academy of Medical Sciences' workshop, Global health diagnostics: research, development
and regulation.
13
14
cause of illness.
fever during
consultation.9
different LMIC.
8O
chola LB et al. (2006). The reliability of diagnostic techniques in the diagnosis and management of malaria in the absence of a gold standard.
Lancet Infectious Diseases 6, 582.
9 Abeku et al. (2008). Determinants of the accuracy of rapid diagnostic tests in malaria case management: evidence from low and moderate
transmission settings in the East Africa highlands. Malaria Journal 7, 202-212.
10 Reyburn H et al. (2007). Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania:
randomised trial. BMJ 334(7590), 403.
15
16
Sample size.
Blinding.
in trials.
The European and American regions showed the highest level of regulation, although
clinical evaluations were not always included and marked variations were evident in the
robustness of evaluations.
83% and 92% of respondent countries regulate HIV and Hepatitis diagnostics respectively,
yet just 42% regulate diagnostics for STIs and only 13% of countries regulate diagnostics
for TB and malaria.
The costs associated with evaluations of diagnostic tests were markedly variable, ranging
between USD2,000 to USD2,000,000.
One particular evaluation assessed performance of the diagnostic test in just 15 patients.12
11 B
lacksell et al. (2006). The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus
infection. Clinical Infectious Diseases 42(8), 1127.
12 World Health Organization (2006). Diagnostics for tuberculosis: global demand and market potential. Annex: Regulation of in vitro diagnostics: a
global perspective. Geneva: WHO, reviewed in Peeling RW et al. (2006). Rapid tests for sexually transmitted infections (STIs): the way forward.
Sexually Transmitted Infections 82(Suppl V), 1-6.
17
decision-makers.
performance characteristics.
qualities.13
18
13 W
HO, WHO/TDR and FIND (2008). Initiative for quality assurance of malaria rapid diagnostic tests. Outline of product testing and associated
protocols. http://www.wpro.who.int/NR/rdonlyres/586DC848-8078-4DDD-85FD-9181E352BF14/0/ProductTestingOverview_final_280208.pdf
14 TDR Diagnostics Evaluation Expert Panel (2007). Evaluation of diagnostic tests for infectious diseases: general principles. Nature Reviews
Microbiology Suppl S17-29. Peeling RW et al. (2007). A guide to diagnostic evaluations. Nature Reviews Microbiology Suppl S2-6.
15 http://www.who.int/diagnostics_laboratory/evaluations/en/
LMIC include:
diagnostics market.
low cost.
For instance:
relevant to LMIC.
co-ordinated process.
prescribed.16
16 Data gathered from World Malaria Report 2008. Geneva, WHO, 2008; Roll Back Malaria (RBM) Commodity database.
http://www.rollbackmalaria.org/gmap/1-3.html,
17 http://www.wpro.who.int/NR/rdonlyres/A15EBA35-91E1-4D8F-9798-5352CEBC7395/0/20_May_2007_RDT_Forecast_report.pdf
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Global health diagnostics
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CONCLUSIONS
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Conclusions
To date, efforts to address the burden of
Access to diagnostics
18 http://www.who.int/hpr/NPH/docs/declaration_almaata.pdf
21
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Global
health diagnostics
industry and the clinical community possibly in regional consortia - could catalyse
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CONCLUSIONS
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Key points
The use of accurate, safe and affordable diagnostic tests has a critical role to play in
addressing the health burden in LMIC. In particular, point-of-care diagnosis using rapid
diagnostic tests that are appropriate to LMIC contexts could revolutionise diagnosis and
treatment in primary healthcare settings. Research and development have a crucial
role to play in the generation of appropriate diagnostics for both infectious and noncommunicable diseases.
Effective advocacy is needed to secure greater investment in: research, development and
delivery of diagnostic tests; infrastructure; equipment; and human resource capacity.
Clearer and more precise data are needed regarding the performance, quality, accuracy and
cost-effectiveness of RDTs in relation to the LMIC contexts in which they are used.
A single global body involving academia, clinicians, the diagnostics industry, pharmaceutical
companies, funding bodies and stakeholders, would play an important role by
providing leadership on behalf of the diagnostics community, and by contributing to the
implementation of regulatory policy.
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Global
health diagnostics
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16.30
Registration
16:45
Opening remarks
17:50
Panel discussion
Dr Mark Perkins, Chief Scientific Officer, Foundation for Innovative New Diagnostics
18:55
Closing remarks
19:00
End
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annex
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Global2:
health
delegate
diagnostics
list
International Health
Wellcome Trust
Medical Microbiology
Population Health
University College London
Ms Paula Kanikadan
PhD Student
Dr Mallika Kaviratne, Technical Officer
Malaria Consortium
Dr Zahra Khatami FRCPath, Consultant Biochemist
BHR Hospitals
Professor Sanjeev Krishna FMedSci, Professor of
Molecular Parasitology and Medicine
St Georges University of London
Professor Ajit Lalvani, Wellcome Trust Senior Clinical
Research Fellow
Imperial College London
Professor Ronald Laskey FRS FMedSci, Honorary
Infectious Diseases
Dr Werner Leber
26
annex
2: delegate list?
University of Cambridge
Wellcome Trust
Epidemiology
27
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Global health diagnostics
28